BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DST SERIES EEA ORVIL 25MM DEVICE

    MDR report key: 2892206 · Received December 21, 2012

    Report

    Report Number
    1219930-2012-01006
    Event Type
    Injury
    Date Received
    December 21, 2012
    Date of Event
    November 27, 2012
    Report Date
    November 28, 2012
    Manufacturer
    COVIDIEN LP, FORMERLY REGISTERED AS UNITED STATES
    Product Code
    GAG
    PMA / PMN Number
    K062850
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: ESOPHAGUS. ACCORDING TO THE REPORTER: EEAXL2535 AND EEAORVIL25 WERE USED FOR ANASTOMOSIS OF ESOPHAGUS AND JEJUNUM. AFTER CUTTING THE ESOPHAGUS WITH TRI-STAPLE PURPLE 45, EEAORVIL25 WAS INSERTED THROUGH ESOPHAGUS AND THE BULB-TIP WAS PULLED OUT FROM THE STUMP, AND THE ANVIL WAS SET. UPON CONNECTING EEAXL2535 AND EEAORVIL25, THERE WAS NO TACTILE CLICK, BUT THEY WERE CONNECTED UNTIL THE ORGANGE BAND ON THE CENTER SHAFT WAS COVERED. HOWEVER, THE CONNECTION WAS LOOSE AND THE ANVIL WAS EASILY DISENGAGED UPON APPROXIMATING THE TISSUE. THE SURGEON CLAMPED THE JOINT OF ANVIL WITH FORCEPS, BUT THE PROBLEM WAS NOT SOLVED. THEREFORE, HE SUTURED THE ESOPHAGUS AND CLAMPED THE STAPLE LINE, AND EXCISED THE ESOPHAGUS WITH ELECTRIC SCALPEL TO REMOVE THE ANVIL. ANOTHER EEAXL2535 WAS OPENED TO COMPLETE PROCEDURE. THERE WAS NO BLEEDING REPORTED IN EXCESS OF 500CC. THERE WAS UNANTICIPATED TISSUE LOSS. THE CASE WAS EXTENDED BY MORE THAN 30 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DST SERIES EEA ORVIL 25MM DEVICE DISPOSABLE SURGICAL STAPLER GAG COVIDIEN LP, FORMERLY REGISTERED AS UNITED STATES NID0405U

    Patients

    Seq Age Sex Outcome Treatment
    1 Other EEA XL 25MM SINGLE USE STAPLER WITH 3.5MM STAPLES| EXPIRATION DATE - 03/30/2016| LOT #: P2C0070XQR, K062850| MANUFACTURED - 03/01/2011| EEAXL2535